DISEPEIN: Initial Parenteral Nutrition Education of Parent Assessment Plan

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT04816734

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The department of gastroenterology, hepatology and pediatric nutrition at the Necker-Enfants Malades hospital has created an evaluation system for the initial therapeutic education program followed by parents of children requiring parenteral nutrition at the Necker-Enfants Malades hospital.

The aim of the study is to test this evaluation plan and assess its interest in the learning process of parents and then include it in the initial therapeutic education program for parents of children requiring parenteral nutrition of Necker-Enfants Malades hospital.

Condition or Disease	Intervention/Treatment	Phase
Parenteral Nutrition	Other: Self-report questionnaires	N/A

Detailed Description

Due to the highly technical nature of the care to be provided at home by parents of children in need of parenteral nutrition, an assessment of the acquisition of both factual knowledge provided to parents in hospital, but also of the reasoning, decision-making, technical skills and parents attitudes seem necessary and essential before the child's return to his home in order to guarantee his safety.

The department of gastroenterology, hepatology and pediatric nutrition of Necker-Enfants Malades hospital has developed an educational assessment system based on previous studies in this field. Composed of 4 tools, this plan allows a complete assessment with relevant educational decision fields of the set of skills that parents must master to cope with their child's illness on a daily basis, following their participation in the initial program of therapeutic education offered by the Necker hospital team.

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Validation of an Educational Evaluation Plan and Assessment of Its Usefulness in Therapeutic Patient Education: Case of Pediatric Home Parenteral Nutrition

Actual Study Start Date :

Mar 25, 2021

Actual Primary Completion Date :

Sep 25, 2021

Actual Study Completion Date :

Sep 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Parents Parents of children in need of home parenteral nutrition and participating in initial therapeutic education program of Necker-Enfants Malades hospital.	Other: Self-report questionnaires Evaluation system of initial therapeutic education program about pediatric home parenteral nutrition. The assessment takes place after the parents have participated in the therapeutic education program and before their child returns home.

Arm

Intervention/Treatment

Experimental: Parents

Parents of children in need of home parenteral nutrition and participating in initial therapeutic education program of Necker-Enfants Malades hospital.

Other: Self-report questionnaires

Evaluation system of initial therapeutic education program about pediatric home parenteral nutrition. The assessment takes place after the parents have participated in the therapeutic education program and before their child returns home.

Outcome Measures

Primary Outcome Measures

Usefulness by parent [Day 1]
Perceived usefulness of the evaluation session by the learners -parents- collected via a self-report questionnaire. 4-point Likert scale: Strongly agree, Somewhat agree, Somewhat disagree, Disagree.

Secondary Outcome Measures

Usefulness by carer [Day 1]
Perceived usefulness of the evaluation session by users -carers- collected via a self-report questionnaire. 4-point Likert scale: Strongly agree, Somewhat agree, Somewhat disagree, Disagree.
Educational quality by parent [Day 1]
Educational quality of the 4 assessment tools, assessed via 4 self-report questionnaires intended for parents. 4-point Likert scale: Strongly agree, Somewhat agree, Somewhat disagree, Disagree.
Educational quality by carer [Day 1]
Educational quality of the 4 assessment tools, assessed via 4 self-report questionnaires intended for carers. 4-point Likert scale: Strongly agree, Somewhat agree, Somewhat disagree, Disagree.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Holders of parental authority for children with parenteral nutrition participating in the initial education program of pediatric home parenteral nutrition of Necker hospital.
informed consent signed by the patient and the investigator.
patient affiliated to a social security scheme (beneficiary or beneficiary).

Exclusion Criteria:

Subject having difficulty understanding the French language.
Illiterate subject.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Necker-Enfants Malades	Paris		France	75015

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Cécile LAMBE, MD, Assistance Publique - Hôpitaux de Paris
Study Director: Cécile GODOT, MD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT04816734

Other Study ID Numbers:

APHP200894
2020-A01159-30

First Posted:

Mar 25, 2021

Last Update Posted:

Jun 8, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Assistance Publique - Hôpitaux de Paris

Parenteral nutrition

Pediatric home parenteral nutrition

Parental therapeutic education

Educational evaluation

Study Results

No Results Posted as of Jun 8, 2022